206906_Covance-Intro 10/18/07 10:39 AM Page i Effective December 2nd, 2007 The iPLEDGE Program Patient Introductory Brochure The important information you need to know about isotretinoin and the iPLEDGE program before starting treatment WARNING For your health and safety, please read this booklet carefully. Also, be sure you understand what your doctor has told you about isotretinoin before starting treatment. Do not take isotretinoin if you are pregnant, plan to become pregnant, or become pregnant during isotretinoin treatment. Isotretinoin causes severe birth defects (deformed babies), loss of a baby before birth (miscarriage), death of a baby and early (premature) births. There is no accurate means of determining whether an exposed fetus has been affected. IMPORTANT NOTICE Use only isotretinoin products approved by the US Food and Drug Administration. Fill and pick up your isotretinoin prescriptions only at pharmacies that are licensed in the United States and are registered with and activated in the iPLEDGE program. 206906_Covance-Intro 10/5/07 3:57 PM Page 1 Are you thinking about taking isotretinoin (eye-soh-tret-in-OH-in) for acne? Read this brochure to learn more about isotretinoin and the iPLEDGE program. 1 206906_Covance-Intro 10/5/07 3:57 PM Page 2 Isotretinoin treats a type of severe acne called nodular acne. It is used after other treatments, including antibiotics, have not helped. It comes in a capsule you take by mouth. Treatment usually lasts 4 to 5 months. There is a very high chance of birth defects if an unborn baby’s mother takes isotretinoin. The goal of the iPLEDGE program is to prevent pregnancies in females taking isotretinoin and to prevent pregnant females from taking isotretinoin. The iPLEDGE program requires birth control for female patients who can get pregnant for at least 1 month before, during, and 1 month after stopping treatment and pregnancy tests before, during, and after treatment. Before starting isotretinoin, you should know about its other serious side effects. Talk with your doctor about how bad your acne is and how isotretinoin can help your skin. Decide if isotretinoin is right for you. Your doctor will ask you to read and sign forms that say you understand the serious risks of isotretinoin. It is important for you to know how to take isotretinoin correctly and what to expect. 2 206906_Covance-Intro 10/5/07 3:57 PM Page 3 WHAT IS THE iPLEDGE PROGRAM? The iPLEDGE program is a set of steps all patients, doctors, and pharmacists must follow. The main goal is preventing pregnancy and birth defects, but both male patients and female patients must follow the iPLEDGE program. To get isotretinoin, all patients must: • Sign the Patient Information/Informed Consent form(s) • Be able to keep appointments • Agree to follow the iPLEDGE program steps WHAT DO MALE PATIENTS NEED TO KNOW ABOUT THE iPLEDGE PROGRAM? • Talk with your doctor about the iPLEDGE program and the possible side effects of taking isotretinoin. • Keep your appointments. You must be able to see your doctor for your prescriptions. Treatment usually lasts 4 to 5 months. • Each prescription is for up to a maximum 1-month supply. WHAT DO ALL FEMALE PATIENTS NEED TO KNOW ABOUT THE iPLEDGE PROGRAM? Are you a female patient who can get pregnant? This includes all female patients who have menstrual periods. It includes young female patients who have not started having menstrual periods. Even a female patient who has had her tubes tied can still get pregnant. If you are able to get pregnant, you need to know how to keep from becoming pregnant. Your doctor has information to help you learn about effective birth control for iPLEDGE. You would not have to follow the birth control requirements of iPLEDGE if: • You have stopped having periods for 12 months in a row (menopause) and your doctor says you are in menopause • You had both of your ovaries or uterus taken out by surgery • Your ovaries do not work and you cannot get pregnant (confirmed by your doctor) • You commit to not having any sexual contact with a male at any time for at least 1 month before, during, and 1 month after your last dose 3 206906_Covance-Intro 10/5/07 3:57 PM Page 4 WHAT DO FEMALE PATIENTS WHO CANNOT GET PREGNANT NEED TO KNOW ABOUT THE iPLEDGE PROGRAM? • Talk with your doctor about the iPLEDGE program and the possible side effects of taking isotretinoin. • Keep your appointments. You must be able to see your doctor for your prescriptions. Treatment usually lasts 4 to 5 months. • Each prescription is for up to a maximum 1-month supply. WHAT DO FEMALE PATIENTS WHO CAN GET PREGNANT NEED TO DO FOR THE iPLEDGE PROGRAM? Plan For Your Isotretinoin Treatment • Talk with your doctor about the iPLEDGE program and the risks of isotretinoin for unborn babies. • Keep your appointments. You must be able to see your doctor for your prescriptions and to get monthly pregnancy tests. Treatment usually lasts 4 to 5 months. • Each prescription is for up to a maximum 1-month supply. Choose 2 Effective Forms Of Birth Control • Not all birth control is acceptable for the iPLEDGE program. Not all forms of birth control can be used together. • Learn what birth control will work for the iPLEDGE program. Choose 2 forms that you really will use together. • Even if you are already using birth control, get this information from your dermatologist, gynecologist, family doctor, or a birth control expert. The iPLEDGE program will pay for a visit for you to learn about birth control. 4 206906_Covance-Intro 10/5/07 3:57 PM Page 5 Use The 2 Effective Forms Of Birth Control Together • You must use both forms together all the time for at least 1 month before you start taking isotretinoin. • There is a 30 day mandatory waiting period during which you must be using both chosen forms of birth control before you are eligible to begin treatment with isotretinoin • You must use both forms together while you are taking isotretinoin • You must use both forms together for 1 month after isotretinoin treatment. Get Blood Or Urine Tests For Pregnancy You must have a negative pregnancy test: • To enter the iPLEDGE program • Before you start isotretinoin • Performed in an approved lab each month before you can fill and pick up your prescription • Right after you finish your last isotretinoin dose • 1 month after you finish your last isotretinoin dose Each Month Before You Can Fill and Pick Up Your Prescription • Your doctor must enter your pregnancy test results in the iPLEDGE system • You must access the iPLEDGE system to answer different questions about the iPLEDGE program and confirm the 2 forms of birth control that you are using. Talk with your doctor about the iPLEDGE program. This information does not replace talking with your doctor about acne or your treatment. If you have any questions, write them down. Ask your doctor before starting isotretinoin. Be sure you understand the answers to all your questions. 5 206906_Covance-Intro 10/9/07 12:50 PM Page 6 REVIEW: THE KEY INFORMATION FOR THE iPLEDGE PROGRAM – FEMALE PATIENTS WHO CAN GET PREGNANT Before You Start Treatment • Learn about isotretinoin and the iPLEDGE program. • Plan for office visits. • Get birth control information. Choose 2 iPLEDGE program acceptable forms of birth control. • Start using both forms of birth control together all the time for at least 1 month before starting isotretinoin. • Have 2 negative pregnancy tests. – The first to get started in the iPLEDGE program, which may be performed in the doctor’s office. – The second before you actually start isotretinoin, performed in an approved lab. • Sign the Patient Information/Informed Consent form(s). • Get a prescription from your doctor. • Before you fill and pick up the prescription, access the system to answer questions about the iPLEDGE program and preventing pregnancy. You can answer your questions after your doctor has entered your pregnancy test result in the iPLEDGE system. • Fill and Pick up your prescription for up to a maximum of a 1-month supply. • Fill and Pick up your prescription within the 7-day prescription window, counting the date of the pregnancy test as DAY 1. Each Month During Treatment • Use 2 forms of birth control together all the time. • Get a prescription for up to a maximum of a 1-month supply. • Have a negative pregnancy test, performed in an approved lab. • Answer questions about the iPLEDGE program and preventing pregnancy. You can answer your questions after your doctor has entered your pregnancy test result in the iPLEDGE system. • Fill and Pick up your prescription for up to a maximum of a 1-month supply and within the 7-day prescription window counting the date of the pregnancy test as DAY 1. • Do not donate blood. After Your Last Dose • Have a pregnancy test after your last dose. • Use 2 forms of birth control together all the time for 30 more days. • Have a last pregnancy test 1 month after your last dose, performed in an approved lab. 6 • Do not donate blood for 30 days after taking your last dose. 206906_Covance-Intro 10/9/07 12:50 PM Page 7 REVIEW: THE KEY INFORMATION FOR THE iPLEDGE PROGRAM – MALE PATIENTS AND FEMALE PATIENTS WHO CANNOT GET PREGNANT Before You Start Treatment • Learn about isotretinoin and the iPLEDGE program. • Plan for office visits. • Sign the Patient Information/Informed Consent form. • Get a prescription from your doctor. • Fill and Pick up your prescription for up to a maximum of a 1-month supply. • Fill and Pick up your prescription within the 30-day prescription window counting the date of the office visit as DAY 1.